Is there a Tepezza hearing loss warning?

On July 20, 2023, the FDA issued an updated version of the prescribing information for Tepezza, which now includes language similar to what lawsuits allege should have been included on the original Tepezza label.

Why did the FDA update the Tepezza warning label?

If new safety concerns are identified, the FDA can require the drug manufacturer to add new warnings or precautions to the drug’s label, or to change the wording of existing warnings to more accurately reflect the current understanding of the drug’s risks. Over the past few years, it has become increasingly clear that a Tepezza warning label update was needed.

What hearing problems can Tepezza cause?

The revised Tepezza advisory now discloses that side effects may cause severe hearing impairment, which is permanent in some cases.

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FDA Approved Tepezza Label Update Now Provides Hearing Loss Warnings

By Austin Kirk
July 25, 2023 | 3 Comments

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FDA Approved Tepezza Label Update Now Provides Hearing Loss Warnings